In this episode, our guests are joined by Syntactx’s Dr. Valerie Merkle, Associate Director – Regulatory Strategy, to discuss NAMSA’s recent acquisition of Syntactx.

During this one-hour installment, Dr. Merkle discusses her deep-rooted experience at the FDA and the importance of proper biological safety planning to achieve biomechanical efficiency and successful clinical trial execution. Examples will be provided regarding how and when biocompatibility programs go wrong, which often result in derailment of development efforts. How can manufacturers create biocompatibility programs that are observed favorably by the FDA? Learn helpful tips and strategies to help ensure a successful FDA submission.

“We really wanted to mirror what we were doing at the FDA.” – Valerie Merkle

“You just never know what is going to come in next. It keeps you on your toes for sure.” – Don Pohl

“People think biocomp is just a checklist, but there are a lot of rabbit holes you can go down—a lot of ways you can stray off the path unnecessarily. Definitely not a checklist item.” – Valerie Merkle

“Make good decisions early-on to not derail yourself later.” – Sheri Krajewski-Bibins

“A lot of companies don’t want to provide their thought process. They spend years and years developing and making decisions, FDA only sees what is in front of them and if the background is not there, we see lots of questions.” – Valerie Merkle

Discussion points include:

• Syntactx company overview and strengths they bring to NAMSA
• Material selection and its importance in avoiding derailment of biocompatibility projects
• FDA experiences with manufacturers overlooking material testing
• FDA biocompatibility guidance and its role in regulatory submissions